The FDA’s approval of Immunic’s investigational new drug (IND) application allows the biotech company to initiate the clinical trial (NCT03341962), which will evaluate the safety and effectiveness of different doses of IMU-838 in 150 adults in the U.S. and Europe with moderate to severe ulcerative colitis (UC).

A second Phase 2 trial is planned by Immunic in Crohn’s disease patients after interim results are collected from the UC study.

IMU-838 is a selective immune system modulator. It is designed to target the intracellular metabolism of immune cells by blocking an enzyme called dihydroorotate dehydrogenase (DHODH).

In this way, the drug inhibits key T-cells as well as activated B-cells that may drive inflammation, without increasing the risk of viral infections. In two past Phase 1 trials, IMU-838 was shown to have good safety and pharmacokinetics (how a drug is processed in the body) properties.

The Phase 2 trial, called CALDOSE-1, is the first part of company’s global development plan designed to demonstrate clinical efficacy of IMU-838 for inflammatory bowel disease (IBD).

Immunic’s drug development programs include small molecule inhibitors for the treatment of UC, Crohn’s disease, and psoriasis. The company’s goal is to start the Phase 2 clinical trials for UC and Crohn’s early this year.

“We are very pleased [to receive] the swift IND approval from the FDA. This will accelerate our development of IMU-838 as a promising candidate for therapies of chronic inflammatory bowel diseases,” Daniel Vitt, chief executive officer of Immunic, said in a press release.

He said the IND approval emphasizes the company’s progress toward a Phase 3 trial to assess the therapy.

Andreas Muehler, chief medical officer of Immunic, said the approval is “a validation of Immunic’s development strategy and an important step for commencing this large international trial.”

The Phase 2 trial for ulcerative colitis is not yet enrolling participants. For more information, visit the clinical trial website here, or email Muehler, the study’s director, at andreas.muehler@immunic.de.

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